GENERIC NAME: CARBAMAZEPINE EXTENDED RELEASE TABLETS - ORAL (kar-bam-AZZ-eh-peen)
BRAND NAME(S): Tegretol XR
WARNING: This drug has rarely caused a severe decrease in bone marrow function (aplastic anemia, agranulocytosis). Your doctor will monitor your blood counts to minimize the chance of this side effect. Keep all medical and laboratory appointments. Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), unusual weakness or fatigue, or easy bleeding/bruising.
USES: Carbamazepine is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It is also used to relieve one type of nerve pain (trigeminal neuralgia). This medication works by reducing excessive nerve signals in the brain and restoring the normal balance of nerve activity.
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HOW TO USE: Take this medication by mouth, usually two times a day with meals, or as directed by your doctor. Swallow the tablets whole. Do not crush, chew, or break them, which can destroy the drug's long action and may increase side effects. Inspect the tablets for chips and cracks. Do not take any damaged tablets. Dosage is based on your medical condition and response to therapy. Your doctor may gradually increase your dose. Follow these directions carefully. For the treatment of trigeminal nerve pain, do not take more than 1,200 milligrams per day. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Take this medication regularly at evenly spaced intervals in order to get the most benefit from it. Remember to use it at the same times each day to keep the amount of medicine in your body at a constant level. Do not take more of this medicine than prescribed or stop taking it without consulting your doctor. Some conditions (e.g., seizures) may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Inform your doctor if your condition does not improve or worsens.
SIDE EFFECTS: See also the Warning section. Nausea, vomiting, dizziness, drowsiness, or unsteadiness may occur as your body adjusts to this medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. An empty tablet shell may appear in your stool, but it is harmless. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, swelling of the ankles/feet, trouble breathing, fatigue, fast/slow/irregular heartbeat, persistent or severe headache, fainting, trouble urinating, change in the amount of urine, decreased sexual ability, unusual eye movements (nystagmus), vision changes, hearing problems, mental/mood changes, pain/redness/swelling of the arms or legs, numbness/tingling of the hands/feet, sun sensitivity, joint pain, hair loss. Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea or vomiting, severe stomach/abdominal pain, yellowing eyes and skin, dark urine, swollen glands, persistent mouth sores. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking carbamazepine, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., phenobarbital, phenytoin) or tricyclic antidepressants (e.g., amitriptyline, desipramine); or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function (bone marrow depression), a certain blood disorder (acute intermittent porphyria). Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood clots, blood vessel disease, heart disease (e.g., coronary artery disease, congestive heart failure, heart rhythm or conduction disorders), kidney disease, liver disease, glaucoma, mental/mood disorders, certain types of seizures (atypical absence seizures), history of decreased bone marrow function due to other drugs. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. This medication is not recommended for use during pregnancy due to the risk of possible birth defects and complications in the infant at birth. Discuss the risks and benefits with your doctor. If you become pregnant while taking this drug, contact your doctor immediately. If you are pregnant, prenatal care including tests for spinal cord defects is recommended. This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section. Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication. In some cases a serious, possibly fatal, drug interaction may occur. This drug should not be used with the following medications because very serious interactions may occur: delavirdine, nefazodone, telithromycin, voriconazole. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anti-seizure medications (e.g., felbamate, valproic acid), lithium, SSRI antidepressants (e.g., fluoxetine), tramadol, drugs affecting liver enzymes that remove carbamazepine from your body (such as azole antifungals-including itraconazole, macrolide antibiotics-including erythromycin, cimetidine, rifamycins-including rifabutin, St John's wort, propoxyphene, danazol, calcium channel blockers-including verapamil). Carbamazepine can cause certain liver enzymes to speed up the removal of other drugs from your body, possibly decreasing their effectiveness. These affected drugs include: caspofungin, cyclosporine, doxycycline, HIV protease inhibitors (e.g., amprenavir, saquinavir), levothyroxine, psychiatric medications (e.g., clozapine, haloperidol, risperidone), theophylline, warfarin. This medication may decrease the effectiveness of birth control products that contain hormones including combination type birth control pills, patches, injections, and implants. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, tricyclic antidepressants such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of those products. This product can affect the results of certain lab tests (e.g., thyroid function, some pregnancy tests). Make sure laboratory personnel and your doctors know you are using this drug.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slowed breathing, loss of consciousness, muscle twitching, uncontrolled movements, very fast heartbeat.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., complete blood count, blood chemistry, kidney and liver function tests, eye exams, carbamazepine blood levels) should be performed periodically to monitor your progress or check for side effects. Keep all laboratory and medical appointments. Consult your doctor for more details. Wear or carry identification indicating you are using this drug.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Call your doctor if you miss more than one dose a day.
STORAGE: Store the US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Store the Canadian product at room temperature below 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.